Category: St. Jude MedicalSyndicate content

Med-tech tax is a hidden blessing, says one industry veteran | MassDevice.com On Call

February 21, 2012 by MassDevice staff

One industry insider stands against the prevailing winds and speculates that the device tax may be a good thing for the industry.

MassDevice On Call

MASSDEVICE ON CALL — The medical device tax may be just the kick the industry needs to reinvigorate lagging research & development efforts, according to an industry insider.

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St. Jude launches Asian FFR economics study

February 17, 2012 by MassDevice staff

St. Jude Medical launches a study to analyze the cost effectiveness of coronary interventions guided by fractional flow reserve measurements in Asia and Australia, using data from the Fame trial of the FFR technology it acquired with the Radi Medical Systems buyout.

St. Jude Medical

St. Jude Medical (NYSE:STJ) is launching a study to examine the economics of coronary interventions using fractional flow reserve in Japan, China, India, Korea, and Australia.

The analysis, based on the results of the Fame trial comparing FFR-guided procedures with those guided by angiography, plus statistics from country-specific percutaneous coronary intervention registries and other studies.

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The Riata ICD lead recall: Two perspectives

February 16, 2012 by MassDevice

By Westby G. Fisher, MD, FACC

Westby Fisher

Robert Hauser, MD published a perspective piece in the New England Journal of Medicine today entitled "Here We Go Again — Another Failure of Postmarketing Device Surveillance." In the piece, he offers these suggestions on how to detect these failures earlier:

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Focus on safety, not efficacy, says former FDA chief | MassDevice.com On Call

February 15, 2012 by MassDevice staff

Former FDA commissioner Andrew von Eschenbach calls on the agency to abandon efficacy testing for new drug and device applications and leave those concerns to post-marketing studies.

MassDevice On Call

MASSDEVICE ON CALL — Former FDA commissioner Andrew von Eschenbach turned heads yesterday by calling on the federal watchdog agency to abandon efficacy testing when considering new drug and device applications.

Eschenbach, who led the agency from 2006 to 2009, called for an overhaul of the FDA's mission statement and urged Congress to leverage user fee negotiations to reassess the agency's performance.

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AngioDynamics details $372M Navilyst buyout details | Wall Street Beat

February 8, 2012 by MassDevice staff

The $372 million buyout of Navilyst medical is expected to add 8 cents per share to AngioDynamics' books during fiscal 2013; also, Orasi Medical closes up shop; Becton, Dickinson reveals medical device tax impact; Abiomed hits 52-week high; analysts' ups and downs; and the MassDevice.com Funding Roundup.

MassDevice.com Wall Street Beat

Financial projections from AngioDynamics (NSDQ:ANGO) about its $372 million deal to acquire Navilyst Medical show that it expects to reap some significant rewards from the merger over the short and long terms.

Doctors helping doctors (and their patients) via social media

February 6, 2012 by MassDevice

By Westby G. Fisher, MD, FACC

Westby Fisher

It was supposed to be a closed meeting attended by doctors who had a large amount of experience dealing with patients with St. Jude Riata leads, a defibrillator lead that recently garnered an FDA Class I advisory (recall) status due to it's high failure rate. Only 55 doctors and a few industry personnel were brought together to try to determine what to recommend to the rest of us who must deal with this problem in the outside (real) world. 

St. Jude lands FDA win for 2 next-gen cardiac ablation catheters | Regulatory Roundup

February 6, 2012 by MassDevice staff

St. Jude Medical wins pre-market approval for its Therapy Cool Path Duo and Safire Blu Duo cardiac ablation catheters, plus a new ablation generator.

St. Jude's ablation systems

St. Jude Medical Inc. (NYSE:STJ) won pre-market approval for 2 next-generation cardiac ablation systems this month, the Therapy Cool Path Duo and Safire Blu Duo catheters.

Both ablation systems use radiofrequency energy to freeze small areas of faulty cardiac tissue in patients with typical trial flutter, a type of arrhythmia in which patients experience abnormal heart rhythms or an abnormally fast heartbeat in the upper chambers of the heart.